Application 090055

Type: ANDA
Sponsor: STRIDES PHARMA

Application Products#

Product, Drug, Ingredient table
Product	Drug	Ingredient	Form	Strength	Reference drug	Reference standard
001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	CAPSULE;ORAL	250MG	No	No

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090055-001	MYCOPHENOLATE MOFETIL	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB		2010-06-10

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090055-001	AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090055-001	MYCOPHENOLATE MOFETIL	250MG	CAPSULE / ORAL	AB	2010-06-10	`e64feba35796…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A090055-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A090055-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090055-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090055-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090055-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090055-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090055-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090055-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090055-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090055-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090055-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090055-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090055-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090055-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090055-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090055-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090055-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090055-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090055-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090055-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090055-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090055-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090055-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090055-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090055-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090055-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090055-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090055-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090055-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090055-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090055-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090055-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090055-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090055-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090055-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090055-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090055-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090055-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090055-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090055-001	AB	1	`e64feba35796…`

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	REMEDYREPACK INC.	77a75d5b-a90d-4ee5-aa8a-6da97d130357	2026-06-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.	3ac54299-15cc-4c7a-8831-60c15a859b85	2025-12-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055 ndc (product): 23155-830
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	Strides Pharma Science Limited	32dd890a-cfe3-4129-bce6-1d3dbe38e4f3	2025-12-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055 ndc (product): 64380-726
Mycophenolate mofetil	MYCOPHENOLATE MOFETIL	AvKARE	339a10c4-e442-de9e-e063-6294a90a6208	2025-04-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090055 application number: ANDA090055

NDC Listings For This Application#

NDC listings for this application page 1 of 1 · 14 matching rows.

NDC, Name, Nonproprietary name table
NDC	Name	Nonproprietary name	Labeler	Marketing category	Status
23155-830	Mycophenolate mofetil	Mycophenolate mofetil	Avet Pharmaceuticals Inc	ANDA	Current
23155-830	Mycophenolate mofetil	Mycophenolate mofetil	Avet Pharmaceuticals Inc	ANDA	Current
60687-427	Mycophenolate Mofetil	Mycophenolate Mofetil	American Health Packaging	ANDA	Current
60687-427	Mycophenolate Mofetil	Mycophenolate Mofetil	American Health Packaging	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Shasun Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current
64380-726	Mycophenolate mofetil	Mycophenolate mofetil	Strides Pharma Science Limited	ANDA	Current

Documents#

Document, Submission type, Date table
Document	Submission type	Date
44545	ORIG	2015-07-06